Tuesday, March 17, 2009

For the past decade, regulatory authorities and pharmaceutical companies have been battling counterfeit and substandard drugs in India. It is estimated that 10% of the drugs in India are counterfeit, which sadly results in many thousands of deaths annually.

Regulatory authorities have been pushing for stricter laws, but have met with resistance from mid-size companies and states who now hold the regulatory authority over medications in their area.

As reported in the New Ledger, the current Indian health minister, Anbumani Ramadoss from Tamil Nadu proposed amendments that would have created a central drug authority, which in principle would have administered the entire drug regulatory system, overseeing drug quality and authorizing product marketing. Unfortunately, the bill failed to pass the lower house and with elections only two months away, we will have to wait to see if the new administration will push it forward.

Meanwhile, the Food and Drug Administration (FDA) is establishing an office in India to oversee exports to the United States. This measure follows a ban on 30 drugs from India’s largest generic manufacturer, Ranbaxy, in 2008